DepressionNCT03849417
Brain Imaging Biomarkers of Pathological Brain Aging in Late-life Depression
An observational study of Depression, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
This study investigates the relationships and differences in PET-MRI brain imaging biomarkers of abnormal aging and behavioral measures in late life depression compared to healthy controls, and evaluates relationships and differences in the same imaging and behavioral measures following electroconvulsive therapy. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- ECT
- How many people
- 128 participants
- Where
- 1 siteBelgium
- Study dates
- 19 Jun 2019to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A consecutive series of hospital in-patients with late-life depression will be recruited from the Department of Old Age Psychiatry within the University Psychiatric Center, KU Leuven, Belgium. Healthy controls will be recruited from the community by researchers affiliated with the Department of Old Age Psychiatry Department \& Translational Neuropsychiatry using traditional means e.g. flyer. All participants will provide written informed consent prior to enrollment in the study in accordance with the Declaration of Helsinki.
Who may be able to join
- Diagnosis of late-life depression according to DSM 5 (patients only)
- Age over 60 years old
- Judged to be in good physical health by the investigator on the basis of medical history
Who cannot join
- history or evidence of psychiatric disease, as assessed by clinical interview (healthy controls only).
- history of major other neurological disorder, or major internal pathology that may make him/her unfit for participation according to the interpretation by the investigator (including cardiac, lung, haematological, gastro-intestinal disorders or cancer);
- current user (including ''recreational use'') of any illicit drugs,including cannabis, or has a history of drug or alcohol abuse;
- had exposure to ionizing radiation (> 1 mSv) in other research studies within the last 12 months;
- has a contra-indication for MRI scanning;
- suffers from claustrophobia or cannot tolerate confinement during PET-MRI scanning procedures; cannot lie still for 60 minutes inside the scanner;
Show all 9Show fewer
- does not understand the study procedures
- unwilling or unable to perform all of the study procedures, or is considered unsuitable in any way by the principal investigator;
- underwent ECT within the last 3 months before enrollment (patients)
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven
Mathieu Vandenbulcke, MD, PhD
About this study
Official title: PET-MRI Biomarkers of Pathological Brain Aging in Late-life Depression
This study investigates the relationships and differences in PET-MRI brain imaging biomarkers of abnormal aging and behavioral measures in late life depression compared to healthy controls, and evaluates relationships and differences in the same imaging and behavioral measures following electroconvulsive therapy. The study tests the hypotheses that late-life depression will be associated with higher levels of accelerated aging and brain disease biomarkers, and that electroconvulsive therapy works by stimulating the reorganization of brain tissue.The data collected with contribute to improved knowledge about the neurobiology of late-life psychopathology and its treatment.
Read the detailed description
This clinical study is a combined single-center, cohort study with a (1) cross-sectional arm evaluating relationships and differences in PET-MR imaging and behavioral measures in 64 patients with late life depression (LLD) compared to 64 healthy controls, and (2) a longitudinal arm evaluating relationships and differences in imaging and behavioral measures in 20 patients receiving ECT as part of their normal clinical management. The study will utilise three PET tracers: (1) [11C]UCB-J, which targets the Synaptic Vesicle Glycoprotein 2A receptor, to estimate synaptic density (2) [18F]MK-6240, which targets tau associated with neurofibrillary tangles, to assess the presence of tau pathology and (3) [18F]-Flutemetamol, which targets beta-amyloid neuritic plaques in the brain, to assess the presence of cerebral amyloidosis. The main aim of the study is to clarify how hippocampal synaptic density, tau, amyloid and white matter lesions, relate to neuropsychological function, stress and ECT in late life depression.
- Conditions
- Depression
- Being tested
- ECT
- Keywords
- Late-life depression, Electroconvulsive therapy, Neuroimaging, Aging
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECTOther
ECT administered as part of normal clinical management
| Study group | Role | What they receive |
|---|---|---|
| Late-life Depression | Patients aged over 60 years old with severe depression | |
| Late-life Depression (ECT) | Patients aged over 60 years old with severe depression who are referred for treatment with electroconvulsive therapy Receives: Other: ECT | |
| Healthy Controls | Healthy volunteers over 60 years old who will form a comparison group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between synaptic density and hippocampal volume in LLD
Cross-sectional association between [11C]UCB-J binding (SUVR) and MRI-based assessment of hippocampal volume
Measured: 1 day
Relationship between tau and hippocampal volume in LLD
Cross-sectional association between [18F]MK-6240 binding (SUVR) and MRI-based assessment of hippocampal volume
Measured: 1 day
Relationship between tau and white matter (wm) pathology in LLD
Cross-sectional association between [18F]MK-6240 binding (SUVR) and MRI measures of white matter pathology (T2-FLAIR WMH/lesions, diffusion MRI measures in temporal lobe tracts)
Measured: 1 day
Effect of tau on medial temporal neural responses to emotional stimuli and functional connectivity in LLD
Cross-sectional association between [18F]MK-6240 binding (SUVR), fMRI based assessment of the emotion positivity effect, and fMRI derived resting state brain networks.
Measured: 1 day
Relationship between medial temporal pathology and stress
Association between [18F]MK-6240 binding (SUVR), hippocampal volume (MRI) and reactivity to stress (EMA) and wristband monitoring of heart rate and skin conductance.
Measured: 1 week
Relationship between hippocampal volume increase following ECT and changes in synaptic density and tau
Association between change in [11C]UCB-J and [18F]MK-6240 binding (SUVR) and MRI-based assessment of hippocampal volume one week following last ECT
Measured: 8 weeks
Amyloid changes following ECT
Change in [18F] Flutemetamol one week following the last ECT treatment
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start19 Jun 2019
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven
- Responsible party
- Sponsor
- Investigators
- Mathieu Vandenbulcke, MD, PhD, Principal investigator, UZ Leuven / UPC-KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849417
- Sponsor's protocol ID
- S61968
- Status last verified
- Nov 2023
- First submitted
- 19 Feb 2019
- Last updated
- 25 Jun 2024
- Results posted
- No
- Individual data sharing
- Undecided: The nature of anonymized IPD data that may be made available will be determined on an ad hoc basis and in adherence with the terms of the informed consent provided by the participants and advice from the local ethics committees and university technology transfer office.
Publications
Van Cauwenberge MGA, Vande Casteele T, Laroy M, Vansteelandt K, Van den Stock J, Bouckaert F, Emsell L, Vandenbulcke M. Motor dysfunction in late life depression: A mood or movement disorder? J Affect Disord. 2025 Jul 15;381:680-691. doi: 10.1016/j.jad.2025.04.053. Epub 2025 Apr 9.
PubMed 40203967Emsell L, Laroy M, Van Cauwenberge M, Vande Casteele T, Vansteelandt K, Van Laere K, Sunaert S, Van den Stock J, Bouckaert F, Vandenbulcke M. The Leuven late life depression (L3D) study: PET-MRI biomarkers of pathological brain ageing in late-life depression: study protocol. BMC Psychiatry. 2021 Jan 28;21(1):64. doi: 10.1186/s12888-021-03063-y.
PubMed 33509135
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET-MRI Biomarkers of Pathological Brain Aging in Late-life Depression
- ClinicalTrials.gov ID
- NCT03849417
- Acronym / sponsor ID
- S61968
- Conditions
- Depression
- Keywords
- Late-life depression, Electroconvulsive therapy, Neuroimaging, Aging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- KU Leuven
- Study start
- 19 Jun 2019 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 21 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the relationships and differences in PET-MRI brain imaging biomarkers of abnormal aging and behavioral measures in late life depression compared to healthy controls, and evaluates relationships and differences in the same imaging and behavioral measures following electroconvulsive therapy. The study tests the hypotheses that late-life depression will be associated with higher levels of accelerated aging and brain disease biomarkers, and that electroconvulsive therapy works by stimulating the reorganization of brain tissue.The data collected with contribute to improved knowledge about the neurobiology of late-life psychopathology and its treatment.
Detailed description
This clinical study is a combined single-center, cohort study with a (1) cross-sectional arm evaluating relationships and differences in PET-MR imaging and behavioral measures in 64 patients with late life depression (LLD) compared to 64 healthy controls, and (2) a longitudinal arm evaluating relationships and differences in imaging and behavioral measures in 20 patients receiving ECT as part of their normal clinical management. The study will utilise three PET tracers: (1) [11C]UCB-J, which targets the Synaptic Vesicle Glycoprotein 2A receptor, to estimate synaptic density (2) [18F]MK-6240, which targets tau associated with neurofibrillary tangles, to assess the presence of tau pathology and (3) [18F]-Flutemetamol, which targets beta-amyloid neuritic plaques in the brain, to assess the presence of cerebral amyloidosis. The main aim of the study is to clarify how hippocampal synaptic density, tau, amyloid and white matter lesions, relate to neuropsychological function, stress and ECT in late life depression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Late-life Depression | – | –Patients aged over 60 years old with severe depression |
| Late-life Depression (ECT) | – | Other: ECTPatients aged over 60 years old with severe depression who are referred for treatment with electroconvulsive therapy |
| Healthy Controls | – | –Healthy volunteers over 60 years old who will form a comparison group |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A consecutive series of hospital in-patients with late-life depression will be recruited from the Department of Old Age Psychiatry within the University Psychiatric Center, KU Leuven, Belgium. Healthy controls will be recruited from the community by researchers affiliated with the Department of Old Age Psychiatry Department \& Translational Neuropsychiatry using traditional means e.g. flyer. All participants will provide written informed consent prior to enrollment in the study in accordance with the Declaration of Helsinki.
Key inclusion criteria (3 listed)
- Diagnosis of late-life depression according to DSM 5 (patients only)
- Age over 60 years old
- Judged to be in good physical health by the investigator on the basis of medical history
Key exclusion criteria (9 listed)
- history or evidence of psychiatric disease, as assessed by clinical interview (healthy controls only).
- history of major other neurological disorder, or major internal pathology that may make him/her unfit for participation according to the interpretation by the investigator (including cardiac, lung, haematological, gastro-intestinal disorders or cancer);
- current user (including ''recreational use'') of any illicit drugs,including cannabis, or has a history of drug or alcohol abuse;
- had exposure to ionizing radiation (> 1 mSv) in other research studies within the last 12 months;
- has a contra-indication for MRI scanning;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECTECT administered as part of normal clinical management | Other | Late-life Depression (ECT) |
Primary outcome
Relationship between synaptic density and hippocampal volume in LLD
Time frame: 1 day
Cross-sectional association between [11C]UCB-J binding (SUVR) and MRI-based assessment of hippocampal volume
Relationship between tau and hippocampal volume in LLD
Time frame: 1 day
Cross-sectional association between [18F]MK-6240 binding (SUVR) and MRI-based assessment of hippocampal volume
Relationship between tau and white matter (wm) pathology in LLD
Time frame: 1 day
Cross-sectional association between [18F]MK-6240 binding (SUVR) and MRI measures of white matter pathology (T2-FLAIR WMH/lesions, diffusion MRI measures in temporal lobe tracts)
Effect of tau on medial temporal neural responses to emotional stimuli and functional connectivity in LLD
Time frame: 1 day
Cross-sectional association between [18F]MK-6240 binding (SUVR), fMRI based assessment of the emotion positivity effect, and fMRI derived resting state brain networks.
Relationship between medial temporal pathology and stress
Time frame: 1 week
Association between [18F]MK-6240 binding (SUVR), hippocampal volume (MRI) and reactivity to stress (EMA) and wristband monitoring of heart rate and skin conductance.
Relationship between hippocampal volume increase following ECT and changes in synaptic density and tau
Time frame: 8 weeks
Association between change in [11C]UCB-J and [18F]MK-6240 binding (SUVR) and MRI-based assessment of hippocampal volume one week following last ECT
Amyloid changes following ECT
Time frame: 8 weeks
Change in [18F] Flutemetamol one week following the last ECT treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Derived from this study: PubMed 40203967Van Cauwenberge MGA, Vande Casteele T, Laroy M, Vansteelandt K, Van den Stock J, Bouckaert F, Emsell L, Vandenbulcke M. Motor dysfunction in late life depression: A mood or movement disorder? J Affect Disord. 2025 Jul 15;381:680-691. doi: 10.1016/j.jad.2025.04.053. Epub 2025 Apr 9.
- Derived from this study: PubMed 33509135Emsell L, Laroy M, Van Cauwenberge M, Vande Casteele T, Vansteelandt K, Van Laere K, Sunaert S, Van den Stock J, Bouckaert F, Vandenbulcke M. The Leuven late life depression (L3D) study: PET-MRI biomarkers of pathological brain ageing in late-life depression: study protocol. BMC Psychiatry. 2021 Jan 28;21(1):64. doi: 10.1186/s12888-021-03063-y.
- Individual participant dataSharing planned: Undecided. The nature of anonymized IPD data that may be made available will be determined on an ad hoc basis and in adherence with the terms of the informed consent provided by the participants and advice from the local ethics committees and university technology transfer office.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mathieu Vandenbulcke, MD, PhD principal investigator
UZ Leuven / UPC-KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mathieu Vandenbulcke, MD, PhD (+32 16 3 48005, mathieu.vandenbulcke@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between synaptic density and hippocampal volume in LLD (time frame: 1 day). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03849417, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2024.